PAS funded by this sponsor. EU PAS ID Status RMP requirementTitle Protocol uploaded Results uploaded 1578 Finalised Unspecified Long-term outcomes and adverse events of therapy with inhaled corticosteroids, long-acting beta-2-agonists and anticholinergic drugs in hospitalised... No No 1587 Finalised Unspecified DEVELOPMENT AND VALIDATION OF A SHORTENED VERSION OF THE SPANISH QUALITY OF LIFE QUESTIONNAIRE FOR INFLAMMATORY BOWEL DISEASE Yes No 1661 Ongoing Unspecified CHARACTERISATION OF PROTEOMIC PROFILES PREDICTIVE OF HEPATOTOXICITY ASSOCIATED WITH ANTI-TUBERCULOSIS DRUGS: A PILOT STUDY No No 2221 Ongoing Unspecified EUROmediCAT: Safety of Medication Use in Pregnancy in Relation to Risk of Congenital Malformations No No 2807 Ongoing Unspecified Patients treated with antipsychotics. A follow-up study (Ícaro) No No 3099 Finalised Not included in RMP Assessment of the safety of LABAs in asthma in routine care by combining healthcare databases and direct patient follow-up (ASTRO-LAB) Yes Yes 3145 Ongoing Not included in RMP Identification of drug-induced liver injury (DILI) cases in Spain, a national DILI registry (Spanish DILI Registry) No No 3209 Finalised Unspecified Persistence with pharmacological treatment in the specialist mental healthcare of patients with severe mental disorders (Persistence of treatment in... Yes No 3238 Planned Unspecified Accuracy of Pleth Variability Index (PVI) in Predicting Response to Intravenous Fluid load During Scoliosis Surgery in Children. No No 3803 Ongoing Unspecified Long-term observational safety study to evaluate the nature and incidence of adverse effects of deferiprone treatment in patients with... No No 3847 Ongoing Unspecified The European Drug-induced Agranulocytosis Consortium Study (The EuDAC Study) Yes No 3985 Ongoing Unspecified Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects observational, open label pharmacovigilance study (ADDUCE) No No 4085 Finalised Unspecified Cost-Effectiveness Analysis of Treatment with Statins in Primary Prevention of Vascular Events (EPREV project) No No 4088 Finalised Unspecified Measurement of the effectiveness of statins in vascular morbidity and mortality reduction in the population without history of vascular disease but... No No 5032 Ongoing Not included in RMP The healthcare costs associated with comorbidities of refractory asthma and systemic steroid exposure in the UK (Refractory Asthma & Steroid Exposure) Yes No 5326 Ongoing EU RMP category 2 LOWER: Lomitapide Observational Worldwide Evaluation Registry (AEGR-733-025) No No 6420 Finalised Not included in RMP Incidence and outcome of paracetamol poisoning No Yes 6539 Finalised Not included in RMP Pharmacoepidemiological Safety Study of Neuroleptics and Antidepressants in the Area of Geriatric Psychiatrics (PhaSiNAg) No Yes 6749 Finalised Unspecified Multi-component assessment systems and predicting future risk in chronic obstructive pulmonary disease No No 7757 Finalised Not included in RMP Adherence to antihypertensive therapy: analysis of initiation, implementation, discontinuation and possible risk factors in Portuguese primary care... Yes Yes 8797 Planned Unspecified MSC-INHP-QHCP-1: Questioner to Health Care Professionals and Regulatory Authorities (Questioner to HCPs and RAs, Study MSC-INHP-8797) No No 8800 Ongoing Unspecified Questioner to cancer patients MSC-INHP-QCP1 (Questioner to cancer patients, Study MSC-INHP-8800) No No 9050 Planned Not included in RMP Low radiant exposures delivered by high-frequency and/or long-pulsed diode laser energy output in hair reduction: an intrapatient comparative,... Yes No 9053 Ongoing Unspecified The efficacy and safety of biosimilar infliximab CT-P13 in IBD: a prospective, nationwide, observational cohort (Biosimilar infliximab in IBD) No No 9209 Finalised Unspecified Comparison of continuous local anaesthetic and systemic pain treatment after axillary lymphadenectomy in breast carcinoma patients - a prospective... Yes Yes 9215 Finalised Unspecified Does a continuous local anaesthetic pain treatment after immediate tissue expander reconstruction in breast carcinoma patients more efficiently reduce... Yes Yes 10239 Finalised Not included in RMP Studies on the impact of vasoconstrictors on the risk of myocardial infarction and stroke (PGRx-VASO) No Yes 10902 Finalised Not included in RMP Pattern of use of incretin-based drugs in clinical practice Yes No 11035 Finalised Unspecified Safety and efficacy of oxycodone/naloxone vs. oxycodone vs. morphine in the treatment of chronic low back pain - a 12-week prospective (optionally... No Yes 11039 Finalised Unspecified DEVELOPMENT OF OPIOID-INDUCED CONSTIPATION: POST-HOC ANALYSIS OF DATA FROM A 12-WEEK PROSPECTIVE, OPEN-LABEL BLINDED ENDPOINT STREAMLINED STUDY IN... No No 11048 Finalised Unspecified DIFFERENTIAL GASTROINTESTINAL EFFECTS OF WHO-STEP III OPIOIDS IN LOW BACK PAIN PATIENTS WITH VS. WITHOUT CONSTIPATION: POST-HOC ANALYSIS OF DATA FROM... No No 11977 Finalised Not included in RMP Safety Alerts: An Observational Study in Portugal (Safety alerts) No No 12171 Ongoing EU RMP category 1 Retrospective Cohort Study on the Risk of Venous Thromboembolism with the use of combined oral contraceptives containing Chlormadinone... No No 12174 Finalised Unspecified Suicide attempts and medications. A retrospective case-control study (Suicide attempt and medications) No No 12872 Finalised Not included in RMP Impact of rosiglitazone safety alerts on oral antidiabetic sales trends: a country-wide study in Portugal No No 13579 Finalised Unspecified Evaluation of the immunomodulatory effects of therapy with Brentuximab (IMMBRE) No No 13586 Finalised Not included in RMP Does the cost of inhaler devices affect therapy adherence and disease outcomes? Yes Yes 13908 Finalised Not included in RMP ADVANCE POC Study Protocol - Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case. Coverage rates of acellular and... Yes Yes 16436 Finalised Not included in RMP Perioperative complication following anaesthesia in children with respiratory infection (RHUBARBE) Yes No 19729 Finalised Not included in RMP Nurses Internal Contamination by Antineoplastic Drugs (CACIES) No No 21151 Finalised Non-EU RMP-only Pregnancy Prevention Program Section of the Risk Management Plan for Soriatane® (acitretin): Survey to Assess Physician and Pharmacist Understanding... Yes Yes 25364 Planned Not included in RMP Spanish Registry of Atopic Dermatitis (BIOBADATOP) No No 25659 Ongoing Not included in RMP Estimating Oral Anticoagulant Comparative Effectiveness in the Setting of Effect Heterogeneity: Comparing Clinical Trial Transport and Observational... Yes No 27465 Ongoing Not included in RMP QALY loss due to respiratory syncytial virus (RSV) infection in children younger than 2 years and their relatives in the Valencian Community and... Yes No 29817 Finalised Not included in RMP DRIVE - Brand-specific influenza vaccine effectiveness in Europe, season 2018/19 (DRIVE 2018/19) Yes Yes 29862 Ongoing Not included in RMP Influence of social deprivation on psychotropic drugs dispensing in adults: a large cross-sectional population-based study in France (ISDepPSY) No No 31322 Finalised Not included in RMP NON-INTERVENTIONAL RETROSPECTIVE EVALUATION OF TOLERABILITY AND EFFICACY OF THE ATYPICAL WHO-STEP III OPIOIDANALGESIC TAPENTADOL PR UNDER REAL-WORLD... No No 31328 Finalised Not included in RMP CANCER PAIN AND TREATMENT CHARACTERISTICS in GERMANY – A CROSS_SECTIONAL ONLINE PATIENT SURVEY (CANPAIN) No No 31805 Planned Not included in RMP Vitamin A supplementation in children hospitalized for measles in a high-income country No No 32033 Planned Not included in RMP Metabolic Profiling of Neuromuscular Diseases (MetabNMD) – subproject SMA No No 32754 Finalised Not included in RMP NON-INTERVENTIONAL RETROSPECTIVE EVALUATION OF TOLERABILITY AND EFFICACY OF TYPICAL ORAL LONG-ACTING WHO-STEP III OPIOID ANALGESICs UNDER REAL-WORLD... No No 32826 Ongoing Not included in RMP Efficacy and tolerability of a 5% lidocaine medicated plaster in adult patients with localized neuropathic pain: a retrospective analysis of... No No 32925 Finalised Not included in RMP Influence of social deprivation on benzodiazepines and antidepressants drugs dispensing among children and adolescents: a large cross-sectional... Yes Yes 33787 Planned Not included in RMP Adverse events and inefficacy of PCSK9 Inhibition with evolocumab or alirocumab in hypercholesTeraemic pAtients. (AKITA) No No 34331 Planned Not included in RMP CASE AND CONTROLS NESTED IN AN AMBISPECTIVE COHORT TO EVALUATE THE EFFECT OF CO-MEDICATION ON THE EVOLUTION OF SARS-CoV-2 CORONAVIRUS INFECTION... No No 34399 Ongoing Not included in RMP INTERNATIONAL COVID-19 CLINICAL EVALUATION REGISTRY: HOPE-COVID 19. (Health Outcome Predictive Evaluation for COVID 19) (HOPE COVID 19) No No 34415 Finalised Not included in RMP EFFECTIVENESS AND SAFETY OF TOCILIZUMAB IN INTERSTITIAL PNEUMONIA WITH SERIOUS RESPIRATORY FAILURE SECONDARY TO SARS-COV-2 INFECTION (COVID-19):... Yes Yes 34469 Planned Not included in RMP Description of the cutaneous manifestations of Covid-19 (COVID-PIEL) No No 34490 Planned Not included in RMP COVID-19: Risk Factors Associated with Respiratory Support Needs in Patients with Viral Disease (COVID-19: US Ventilator Use) No No 34494 Planned Not included in RMP COVID-19: Viral Pneumonia – Understanding Disease Presentation, Risk Factors and Healthcare Utilization, Including Ventilator and Extracorporeal... No No 34541 Finalised Not included in RMP Association of ACE inhibitors and AT1R blockers and prognosis in hospitalized COVID-19 patients: a cohort study in Italy (ITA-COVID: RAS INHIBITORS) Yes No 34551 Planned Not included in RMP Observational Study of Follow-up of Hospitalized Patients Diagnosed With COVID-19 to Evaluate the Effectiveness of the Drug Treatment Used to Treat... No No 34604 Ongoing Not included in RMP ASSOCIATION BETWEEN THE USE OF DRUGS IN CHRONIC PAIN AND THE INCIDENCE AND SEVERITY OF COVID-19 INFECTION: A CASE-POPULATION STUDY (DC-COVID19) No No 34663 Ongoing Not included in RMP Pharmacological risk factors for COVID-19 infection: a matched prospective cohort study of patients in primary care No No 34714 Planned Not included in RMP Association between renin-angiotensin-aldosterone system (RAAS) inhibitors and severe outcomes among patients exposed with SARS-COV2: a retrospective... No No 34743 Planned Not included in RMP Clinical features of COVID-19 in Pediatric Patients (COPP-study) No No 34753 Finalised Not included in RMP EFFECTIVENESS AND SAFETY OF CORTICOSTEROIDS IN SARS-COV-2 INFECTION (COVID-19): COHORT STUDY (CORTICOV-19) Yes No 34806 Ongoing Not included in RMP Observational study to evaluate the potential effects of biological, biosimilar, and targeted synthetic disease-modifying antirheumatic drugs in the... Yes No 34826 Finalised Not included in RMP Incidence of Central Retinal Artery Occlusion in the Neovascular Age-related Macular Degeneration Population (RAO in neovascular AMD) Yes Yes 34925 Planned Not included in RMP TREATMENT WITH BISMUTE SUBCITRATE IN FRAGILE PATIENTS WITH SARS-CoV-2 INFECTION AND DIARRHEA NOT FITTING FOR TRANSFER TO ACUTE HOSPITAL (COVID-19)... Yes No 34934 Ongoing Not included in RMP VILA-COVID 19 RETROSPECTIVE OBSERVATIONAL CLINICAL STUDY PROTOCOL: EARLY ADMINISTRATION OF CORTIC THERAPY AND ANTI-INFLAMMATORIES IN PATIENTS WITH... Yes No 35528 Planned Not included in RMP Hidroxicloroquine and cloroquine safety profile in patients with SARS-COV-2 infection (COVID-19) (SEHISACoV-2) No No 35685 Finalised Not included in RMP DRIVE - Brand-specific influenza vaccine effectiveness in Europe, season 2019/20 (DRIVE 2019/20) Yes Yes 35712 Finalised Not included in RMP Patient´s perspective: emotional impact of the COVID-19 pandemic in psoriasis patients treated with biological drugs and small molecules in real... No Yes 35897 Finalised Not included in RMP Inhaled corticosteroids and COVID-19 morbidity: Nationwide cohort study Yes No 36560 Planned Not included in RMP INFLUENZA AND ACUTE MYOCARDIAL INFARCTION IN THE COMMUNITY OF MADRID: A RETROSPECTIVE ECOLOGICAL TIME-SERIES STUDY (2013-2018) (FLU-AMI-ECO) No No 37225 Planned Not included in RMP Project Sc(y)lla: SARS-Cov-2 Large-scale Longitudinal Analyses on the comparative safety and effectiveness of treatments under evaluation for... Yes No 37318 Planned Not included in RMP Impact of the COVID-19 pandemic in a cohort of anticoagulant users: a descriptive drug utilization study based on data from the Tuscany Healthcare... Yes No 37983 Planned Not included in RMP Comparative Effectiveness and Safety of Drugs used in Rare Neuromuscular and Neurodegenerative Diseases (CAESAR) No No 38235 Finalised Not included in RMP Assessment of the prophylactic effect of chloroquine/hydroxychloroquine on the COVID-19 hospitalization and mortality risk in patients with rheumatic... No No 38308 Ongoing Not included in RMP Comparative Effectiveness and Safety of Immunosuppressive Drugs in Transplant patients (CESIT) No No 38332 Finalised Not included in RMP A real world evidence study from Germany on the safety and efficacy of tapentadol and typical oral long-acting opioid analgesics in chronic low back... No No 38484 Ongoing Not included in RMP Effectiveness and tolerability of high-dose methocarbamol vs. typical strong and long-acting opioidanalgesics (LAO) as add-on measure in patients with... No No 39679 Planned Not included in RMP COVID-19 vaccine effectiveness at primary care level in Europe: generic protocol (I-MOVE-COVID primary care VE) Yes No 39683 Planned Not included in RMP European study of COVID-19 vaccine effectiveness against hospitalised SARI patients laboratory-confirmed with SARS-CoV-2 (I-MOVE-COVID VE hospital... No No 39736 Planned Not included in RMP Study of Vaccine Efficacy in Health Care Workers (PSVEHCW) No No 39805 Ongoing EU RMP category 3 Active surveillance of overdose with a prolonged-release formulation of tramadol/paracetamol. The PICS study. No No 40259 Planned Not included in RMP EUMAEUS: Evaluating Use of Methods for Adverse Event Under Surveillance (for vaccines) Yes No 40875 Finalised Not included in RMP DRIVE Brand-specific influenza vaccine effectiveness in Europe, season 2020/21 (DRIVE 2020/21) Yes Yes 41469 Finalised Not included in RMP Adaptation and Validation of the Italian Singing Voice Handicap Index-10 (SVHI-10-IT) (Validation of I-SVHI) No No 42993 Planned Not included in RMP Cohort study to quantify the risk of glaucoma with intravitreal VEGF inhibitors (bevacizumab, ranibizumab, aflibercept) No No 43218 Planned Not included in RMP Using primary care data to understand Opioid Prescribing, Policy Impacts and Clinical Outcomes: A protocol for the OPPICO Study No No 43738 Planned Not included in RMP Impact of the 2016 Nice terrorist attack on mental health service utilization in children and adolescents: Protocol for the PEDIMPACT Study No No 43831 Planned Not included in RMP ANGIOtensin Agents and Reduction of AntiDEPRESSANT Drugs' Prescription (ANGIODEPRESSANTS): A Cohort Study Using Real-World Data. No No 45205 Ongoing Not included in RMP Delineating a full phenotype of health, neurodevelopment and adaptive functioning in children and young adults with Fetal Valproate Spectrum Disorder. Yes No 45365 Ongoing Not included in RMP Biological drugs in patients with psoriasis: a drug-utilization study using Tuscan administrative data banks No No 45959 Planned Not included in RMP Quality of adverse event reporting in clinicals trials of COVID-19 drugs : a systematic review Yes No 46888 Finalised Not included in RMP DRIVE - Brand-specific influenza vaccine effectiveness in Europe, season 2021/22 (DRIVE 2021/22) Yes Yes 48079 Ongoing Not included in RMP Utilisation of low-dose rivaroxaban in patients with atherosclerotic cardiovascular disease in the united kingdom and the netherlands No No 48105 Planned Not included in RMP ANALYSIS OF TREATMENT PATTERNS WITH DISEASE MODIFYING THERAPIES (DMTs) AMONG PATIENTS WITH MULTIPLE SCLEROSIS Yes No 48284 Ongoing Not included in RMP Psilocybin in patients with fibromyalgia: EEG-measured brain biomarkers of action (Psilopain) No No 48481 Finalised Not included in RMP The Effects of ARBs, ACEis, and Statins on Clinical Outcomes of COVID-19 Infection Among Nursing Home Residents No Yes 48603 Planned EU RMP category 3 Testing Fraternity (testing) No No 49718 Finalised Not included in RMP Pridinol vs. nsaids - efficacy/tolerability in acute (low) back pain. A propensity-score matched, comparative 2-cohort, 4-week real world evidence... No No 50070 Ongoing Not included in RMP Efficacy and tolerability of the non-benzodiazepine antispasmodic methocarbamol for the short-term treatment of acute low back pain over 3 days -... No No 104219 Planned Not included in RMP Comparing Database Harmonisation Methods Applied to Real-World Electronic Healthcare Data No No 105418 Ongoing Not included in RMP Comparing the risk of metoprolol-related adverse drug reactions between women and men with heart failure using effectiveness outcomes as a proxy: a... No No 107327 Ongoing Not included in RMP Prevention of gastric cancer by eradication of Helicobacter pylori infection No No 107501 Finalised Not included in RMP Pain characteristics of patients recommended total knee arthroplasty due to painful osteoarthritis – a cross-sectional analysis of depersonalized... No No 107902 Planned Not included in RMP AI-powered stratification of autoimmune diseases No No